Is Community Based Monitoring of Diabetic Maculopathy and Pre-proliferative Diabetic Retinopathy Safe?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHywel Dda Health Board

About this trial

To assess a pathway using opticians based in their practices and a 'virtual' review by a consultant ophthalmologist, based in the hospital to assess suspected diabetic maculopathy. We want to know if this pathway works, is it acceptable to people with diabetes and what the changes might mean in terms of the outcomes for patients and NHS resources and cost?

Screening by Diabetic Eye Service Wales currently involves taking and as-sessing 2-D (dimensional) digital photographs of the back of the eye (reti-na). Leakage from damaged blood vessels can cause swelling within the central part of the retina, known as maculopathy. This swelling cannot be seen on traditional 2-D images.

Diagnosing maculopathy requires a 3-D camera and a technique known as Optical Coherence Tomography (OCT). OCT is not part of routine screening but, is available in the Hospital Eye Service (HES) and many optician prac-tices. If any changes are seen in the macular region of the retina on 2-D images, the patient will require an OCT scan to see if there is any in-creased thickness. Many patients do not have increased thickness and not everyone with diabetic retinopathy has maculopathy.

Currently after screening, patients who have macular changes that suggest possible maculopathy are referred to the HES for OCT imaging. Many of these patients will not have increased thickness and the appointment could have been better used to see a different patient with increased thickness that requires treatment.

The new pathway that will be investigated in this study involves trained opticians in practices that have an OCT camera taking the required 3-D images and carrying out the initial examination. The images and patient record will then be reviewed by an ophthalmologist working virtually, to decide the management plan. If this pathway is safe and acceptable to people with diabetes, it would reduce the pressure on HES clinics. It will also develop new skills for opticians and allow people to be seen closer to their home, reducing the stress that referrals can create and lowering the carbon footprint of the service.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

People with diabetes referred to the hospital eye services for review of suspected diabetic maculopathy or pre-proliferative diabetic retinopathy in HDdUHB

Disqualifiers

<18 years

People with diagnosed diabetic macular oedema

People with proliferative diabetic retinopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Community based optometry with Virtual Review

    Other intervention

    Community based OCT imaging with optometrist and virtual review by ophthalmologist

  • Usual Care

    Other intervention

    Hospital eye services review conducted by an ophthalmologist

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time from referral to treatment

Time taken from referral to ophthalmology to first treatment in ophthalmology

Time frame
From referral to the time of treatment at 6 months

Secondary outcomes

1

Time from referral to being seen

Time taken from referral to being seen at first appointment

Time frame
Time taken from enrollment ti first appointment within 3months
2

Prevalence

Number of people identified as having diabetic maculopathy or pre-proliferative diabetic retinopathy

Time frame
At baseline
3

Hospital to Community PREM questionnaire

Patient report experience measures using the hospital to community PREM

Time frame
Day 1
4

Total number of appointments in ophthalmology

Total number of appointments in ophthalmology needed per patient in both arms

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hywel Dda Health Board

Lead sponsor

Swansea University

Collaborator